Outcomes in Emergency Laparotomies During COVID-19 Pandemic

COVID-19 Clinical Trial

Official title:

Emergency Laparotomies and Outcomes During the COVID-19 Pandemic - a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419571
• Other study ID #: 133196
• Status: Completed
• Start date: March 23, 2020
• Est. completion date: June 16, 2020

Study information

• Verified date: July 2020
• Source: Barking, Havering and Redbridge University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

NLR has previously been observed to correlate with complications in upper GI (1) and colorectal (2) surgery. The investigators sought to assess if a similar correlation can be identified in emergency general surgical patients and if the presence of suspected or confirmed COVID-19 may impact on this.

Given the heterogeneity of emergency general surgery the investigators therefore plan to perform a retrospective review of patients having emergency laparotomies only at a single NHS site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a predictor of outcomes will be completed. Outcomes will be completed in line with the recent COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are 7-day mortality, re-operation, length of stay, post-operative respiratory failure, post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing emergency laparotomy (change made due to heterogeneity of emergency general surgery)

Exclusion Criteria:

• Inherited or acquired immunodeficiency (which may directly skew NLR)

Related Conditions & MeSH terms

• COVID-19
• Emergencies
• Emergency General Surgery

Intervention

Procedure:
• Emergency Laparotomy
All adult patients undergoing emergency laparotomy

Locations

Country	Name	City	State
United Kingdom	Queen's Hospital	Romford

Sponsors (1)

Lead Sponsor	Collaborator
Barking, Havering and Redbridge University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. Epub 2006 Jun 27. — View Citation

Vulliamy P, McCluney S, Mukherjee S, Ashby L, Amalesh T. Postoperative Elevation of the Neutrophil: Lymphocyte Ratio Predicts Complications Following Esophageal Resection. World J Surg. 2016 Jun;40(6):1397-403. doi: 10.1007/s00268-016-3427-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other complications	Other documented post-operative complications	30 days
Other	Peri-operative NLR	Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period	First 3 post-operative days
Other	Post-operative platelet counts	Absolute platelet counts recorded daily in the peri-operative period	First 3 post-operative days
Other	Post-operative coagulopathy	Defined as the presence of increased PT (prothrombin time) OR APTT (activated partial thromboplastin time) OR TT (thrombin time) OR fibrinogen above 1.5X the upper limit of normal. Coagulation will either be defined as normal or abnormal for each patient if one or more of these derangement are identified.	First 3 post-operative days
Primary	30-day mortality	Mortality	30 days
Secondary	7-day mortality	Mortality	7 days
Secondary	Number of participants returning to theatre	Re-operation	30 days
Secondary	Length of stay	Inpatient stay during index admission	30 days
Secondary	Post-operative respiratory failure	Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries	30 days
Secondary	Post-operative ARDS	ARDS diagnosed radiologically	30 days
Secondary	Post-operative sepsis	Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries	30 days
Secondary	ITU/HDU admission	ITU/HDU admission post-operatively	30 days

External Links

•   CovidSurg Cohort Study. Globalsurg.